Internal audits ISO 13485

Especially in the field of medical devices, internal audits are not only necessary for maintaining and improving the quality management system—they are also intended to implement the technical and regulatory aspects of ISO 13485. In this in-house training, you will deepen your technical knowledge for conducting an internal audit according to ISO 13485.

Our expert, DI Martin Schmid, will explain to you in a practical manner how you can competently and professionally conduct your internal audits using the right document templates and tools. In role-playing exercises, you will train the practical approach!

Participants

This practical training is only suitable for participants with prior knowledge of ISO 13485. As optimal preparation, we recommend our basic course: ISO 13485:2016.

The seminar contents

• Fundamentals:
  – Internal audits according to ISO 13485:2016
  – Process management
• The audit process:
  – Audit program
  – Audit preparation
  – Audit execution
  – Audit report
  – Conclusion
• Audit execution according to ISO 13485:2016:
  – Reasons and objectives for audits
  – Definitions
  – Audit methods
  – Good audit practice
  – Auditor qualification
• Practice example / role-play:
  – Audit program,
  – Audit plan &
  – Audit execution
• Best practice: Typical strengths and weaknesses in certification and surveillance audits

Costs

1 day in-house training: EUR 3.890 (excluding VAT) for up to 10 participants
including seminar materials and certificate of attendance, plus travel expenses

your trainer

DI Martin Schmid, Managing Director & Senior Consultant en.co.tec
Information about our trainers

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491